Systems, apparatus and methods for continuously tracking medical items throughout a procedure

ABSTRACT

Systems, methods and apparatus are disclosed for improving medical procedures and medical procedure management, and, more particularly, for tracking medical instruments throughout a procedure and assisting medical personnel throughout the procedure or at least at the conclusion of the procedure. In one form, an apparatus for tracking medical instruments throughout a procedure is disclosed having a single camera for tracking movement and/or detecting position of a plurality of medical instruments during a medical procedure as at least one of the plurality of medical instruments is moved between multiple zones at least including a first prep zone and a second procedure zone. The apparatus having a controller connected to and collecting images from the camera, and a display in electrical communication with the controller and/or the camera for displaying medical instrument data pertaining to the movement and/or position of the plurality of medical instruments.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/804,345, filed Nov. 6, 2017, and claims the benefit of U.S.Provisional Patent Application No. 62/511,718, filed May 26, 2017, whichare incorporated herein by reference in their entirety.

FIELD

This invention relates generally to systems, methods and apparatus forimproving medical procedures and medical procedure management, and, moreparticularly, to systems, methods and apparatus for tracking medicalinstruments throughout a procedure and assisting medical personnelthroughout the procedure or at least at the conclusion of the procedure.

BACKGROUND

Medical procedures have evolved over time into very efficient andwell-choreographed routines, often using pre-packaged surgical kitscontaining all instruments and equipment needed for the particularprocedure at hand. However, these routines often involve numerousmedical personnel working with a litany of different tools and pieces ofequipment, often times in a relatively small or cramped space. This istrue whether the procedure is being performed in a clinical setting orin a high-tech operating room. In such procedures and environments, oneof the most difficult things to do is track all tools, equipment oritems being used during the procedure to make sure all are accounted forat the end of the procedure and that none are left where they shouldn'tbe left.

Conventional systems exist to track various items throughout a medicalprocedure, but all have their own shortcomings. For example, smartsponge systems exist that track how many sponges have been used during aprocedure, how many have been returned or discarded, and how many remainout and unaccounted for. Often these systems are blind systems thatsimply note when an item is unaccounted for and require medicalpersonnel to use equipment, such as scanners to scan items beingchecked-out or used, and then items, such as wands with integralantenna, to waive over a medical procedure area (e.g., over a patient,over surrounding patient support surfaces (like bedding, gurneys,tables, etc.), surrounding equipment, personnel, etc.) to locate theunaccounted for item. This takes up valuable time and does not providethe medical personnel with any additional information that would behelpful in locating the unaccounted for item.

Often times, these systems are also limited to a particular item and/oronly track a small portion of a medical procedure area. For example,some smart sponge systems consist of a cart that includes a wastereceptacle or bucket. Such systems limit their product tracking tosponges alone and ignore the numerous other items utilized during aprocedure (e.g., scalpels, scissors, tongs, gauze, mesh, etc.). Theyalso only track what is checked out and what is returned to thereceptacle and do not track the surrounding procedure area. As mentionedabove, they provide an antenna wand to search the surrounding procedurearea that is not being tracked, but that requires medical personnel toperform additional tasks and is different from actually tracking aprocedure area.

Some conventional systems go beyond tracking sponges, but these systemsoften require medical personnel to apply machine readable labels on allitems that are to be tracked, which is again labor intensive and addsmore work for medical personnel, rather than reduces the steps they haveto perform so they can focus on the procedure at hand and do soefficiently to make the best use of what often is very expensivehigh-tech operating room time. These systems often include interrogatorsthat communicate with a base command unit to track a location of anobject that has been marked with a machine readable label so that theitem can be tracked. Less intelligent versions of such systems are alsoemployed that simply use metal detection technology to detect if anyitem has been left behind in sensitive areas.

Even in instances where medical kits are provided with pre-marked orpre-labeled items so that they can be tracked easier, these systemslimit the tracking to those items in the kit and not additional itemsthat may need to be employed during a procedure. In such systems, thefocus is again on tracking a limited number of items and the proceduralarea, and again, the system operates blind either simply notifyingpersonnel of a missing item or requiring personnel to scan surroundingarea to locate the missing item.

Another problem associated with conventional systems is that they oftenrely too heavily on computer readable indicia that can only be detectedby the electronic equipment used by the medical personnel. Thisprecludes the medical personnel from being able to do their ownsecondary check for redundancy purposes and can leave medical personnelfeeling concerned after a procedure is concluded because they do nothave their own way to independently verify or confirm instrumenttracking was complete.

Accordingly, it has been determined that a need exists for systems,methods and apparatus for improving medical procedures and medicalprocedure management, and, more particularly, to systems, methods andapparatus for tracking medical instruments throughout a procedure andassisting medical personnel throughout the procedure or at least at theconclusion of the procedure.

BRIEF DESCRIPTION OF THE FIGURES

Embodiments of the invention are illustrated in the figures of theaccompanying drawings in which:

FIGS. 1A-1B are perspective and top views, respectively, of a medicalprocedure area and an exemplary system or apparatus in accordance withembodiments of the present invention for improving medical proceduresand medical procedure management, and tracking medical instrumentsthroughout a procedure and assisting medical personnel throughout theprocedure or at least at the conclusion of the procedure;

FIGS. 2A-E are exemplary screen displays of a system or apparatus inaccordance with embodiments of the present invention for improvingmedical procedures and medical procedure management, and trackingmedical instruments throughout a procedure and assisting medicalpersonnel throughout the procedure or at least at the conclusion of theprocedure;

FIG. 3 is a flow chart illustrating an exemplary process a system orapparatus in accordance with embodiments of the invention may follow forimproving medical procedures and medical procedure management, andtracking medical instruments throughout a procedure and assistingmedical personnel throughout the procedure or at least at the conclusionof the procedure;

FIGS. 4A-C are perspective views of a procedural prep table and/or drapefor same in accordance with embodiments of the invention, with FIG. 4Aillustrating a folded drape having integral directions for installationand integral machine detectable indicia for use with the systems andapparatus discussed herein, FIG. 4B illustrating the drape partiallyunfolded on the prep table, and FIG. 4C illustrating the drapecompletely unfolded (or fully deployed/installed) on the prep table inaccordance with embodiments of the invention;

FIG. 5 is a perspective view of a custom procedure kit in accordancewith embodiments of the invention and having indicia for indicating thecontents of the kit and for the medical personnel to note what itemshave been used from same; and

FIG. 6 is a perspective view of a patient support and surgical drape inaccordance with other embodiments of the invention and having machinedetectable indicia for defining boundaries of the procedural area toassist in tracking items used during the procedure and identifying wherethese items may be found.

Elements in the figures are illustrated for simplicity and clarity andhave not necessarily been drawn to scale or to include all features,options or attachments. For example, the dimensions and/or relativepositioning of some of the elements in the figures may be exaggeratedrelative to other elements to help to improve understanding of variousembodiments of the present invention. Also, common but well-understoodelements that are useful or necessary in a commercially feasibleembodiment are often not depicted in order to facilitate a lessobstructed view of these various embodiments of the present invention.Certain actions and/or steps may be described or depicted in aparticular order of occurrence while those skilled in the art willunderstand that such specificity with respect to sequence is notactually required. The terms and expressions used herein have theordinary technical meaning as is accorded to such terms and expressionsby persons skilled in the technical field as set forth above exceptwhere different specific meanings have otherwise been set forth herein.

Similar features shown in the different embodiments illustrated in thefigures above share similar reference numbers. Each element has a threedigit reference number, with the first digit representing the embodimentnumber and the last two digits representing the component. Other thanthe differences explicitly described and/or shown, elements withcorresponding elements are understood to be substantially similar.

DESCRIPTION OF THE INVENTION

Many variations of system or apparatus for improving medical proceduresand medical procedure management are illustrated herein. In someembodiments, the system comprises a medical procedure monitoring systemcapable of monitoring an entire medical procedure room and tracking allitems used therein. In other embodiments, a medical procedure prep tableor cart are disclosed which are capable of monitoring the prep tablearea and/or the entire procedural area. In yet other forms, customprocedural kits, drapes, patient supports and/or zone markers aredisclosed which are equipped with items for improving medical proceduresand medical procedure management in accordance with the inventionsdisclosed herein. While it is contemplated that these items will beprovided to work with an overall system, it should also be understoodthat they may be provided individually and intended to work with thirdparty zones, as may be desired.

Turning first to FIGS. 1A-B, there is disclosed system or apparatus inaccordance with embodiments of the present invention for improvingmedical procedures and medical procedure management, and trackingmedical instruments throughout a procedure and assisting medicalpersonnel throughout the procedure or at least at the conclusion of theprocedure. The layout illustrated in FIG. 1A is slightly different thanthe layout in FIG. 1B in that FIG. 1A illustrates a single tray and awaste area, whereas FIG. 1B illustrates a tray with a startinginstrument location and a used/discarded instrument location as well asother areas of the surrounding environment. While these embodimentsdiffer slightly, they could be interchanged with one another and, thus,are treated such that common items use similar reference numerals. Forexample, in the forms illustrated, the system or apparatus are referredto generally by reference numeral 100 and include a camera 110positioned for viewing a procedural area (e.g., whether that be limitedto a prep table, a larger portion of the procedural area beyond just theprep table, the entire room, etc.) so that the system or apparatus 100can track movement and/or detect positioning of a plurality of medicalinstruments during a medical procedure as at least one of the pluralityof medical instruments is moved between multiple zones at leastincluding a first prep zone and a second procedure zone. The system orapparatus 100 further includes a controller 112 connected to the camera110 (e.g., in the instant embodiment it is integral to the camera 110,but could otherwise be connected remotely via a direct connection or anetwork connection, etc.) to collect images form the camera 110. In apreferred form, a display 170 will be in communication with thecontroller and/or the camera for displaying medical instrument datapertaining to the movement and/or position of the plurality of medicalinstruments via system or apparatus 100.

A variety of different types of cameras may be employed for camera 110,however, in a preferred form, system or apparatus 100 will only requireone camera 110 for monitoring the desired procedural area, rather thanrequiring two or more cameras for monitoring specific portions of theprocedural area (e.g., one camera for the prep table, another camera forthe patient area, another camera for the waste receptacle(s), etc.). Thecamera 110 will be connected to the system or apparatus 100 via eitherdirect connection via cable or wireless connection (e.g., RF transceiversetup, Wi-Fi, NFC, Bluetooth/BLE, etc.) or via a network interface whichmay also be wired (e.g., Ethernet, USB, etc.) or wireless (RF, Wi-Fi,NFC, Bluetooth/BLE, etc.). In the form shown in FIG. 1A, the controller112 is located on the camera 110, however, in the form illustrated inFIG. 1B, the controller 112 is connected to or integrated into display170. The camera 110 may either be permanently mounted or at leastremovably mounted in the procedural area (e.g., connected to theceiling, light fixtures, existing medical equipment carts or towers,etc.), however, in alternate forms, the camera may be mounted to amobile cart that is brought into the procedural area by the medicalpersonnel and not left there permanently.

Similar to the camera 110, a variety of different displays may beemployed for display 170. In a preferred form, the display 170 is afreestanding display that has wheels to make it mobile. However, inalternate embodiments, the display may be a component of equipmentalready contained in the procedural area (e.g., mounted to a wall,fixture, existing medical cart or tower, etc.), may be coupled to amobile prep table that is moved into the procedural area when needed,and/or may be a remote electronic device, such as a smart phone ortablet computer. In some forms, the system or apparatus 100 may be appbased and utilize a software application that is downloaded to a smartphone or other mobile device to interact with the remainder of thesystem or apparatus 100. In this way, users of the system (e.g., medicalpersonnel), can utilize their own devices rather than having to bring inyet another component to a potentially already crowded procedure area.For example, in one form, the system 100 is equipped with a handheldscanner that is app based for scanning the surrounding environment tolocate items identified as missing. The handheld device will preferablywork in connection with the system 100 so that as the device isapproaching the area where the missing device is detected the systemwill alert the user of his/her proximity to the missing item (e.g., suchas by a visual que on display 170, an audible que provided by thesystem, etc.) in addition to the handheld device alerting the user tothe proximity of the missing item (e.g., such as by providing anothervisual que on the display of the handheld or via the app, providing anaudible que from the handheld, etc.). In still other forms, any one ormore of such notification techniques may be utilized by the system toalert the user of the proximity of the missing item.

In the form illustrated in FIGS. 1A-B, the system or apparatus 100 iscontained within the procedural area, however, it should be understoodthat in alternate embodiments, the system may connect to a remotecentral controller (e.g., a remote processing center, remote centralserver, remote central processing unit, etc.). In such instances, theremote central controller may be connected via a wide area network, suchas the interne (e.g., cloud based, etc.) and located off-site or it maybe located on-site and connected via a local area network or otherconventional types of networks. The system or apparatus 100 may be setupwith on-site equipment being configured in a fat or thick clientconfiguration where the on-site equipment handles processing and richfunctionality independent of the central server, or it may be setup inthin client configuration where the central server handles some or allof the processing of the data collected from the on-site equipment (orequipment located in the procedural area). It should be understood,however, that even if fat/thick client configurations are used, thesystem or apparatus 100 may be configured to relay data to a remotecontroller, such as a central server, in order for the data to becollected in a database and mined for relevant information. For example,the data may be used and/or analyzed to determine common traits behindthe most effective procedures (e.g., best practices for specific typesof procedures). It may be used to determine what instruments should beincluded in kits customized for certain procedures (e.g., so as to cutdown on waste, etc.). It may also be used to rate medical personnelperformance and/or facility performance (e.g., clinic performance,hospital performance, etc.). Another use may be for medical personnel inthat the data may be used to determine what order a particular medicalpersonnel or team (e.g., surgeon, surgical team, etc.) prefer to performprocedures in so that medical personnel tasked with prepping theprocedural area can have the desired equipment ready to go in thatorder.

In the form illustrated in FIG. 1A, the procedural area includes aprocedural instrument surface or tray 114 containing instrumentsrequired for the desired procedure, such as sponge 160 and scalpel 162.In a preferred form, the tray 114 will be a sterilized tray containingsterilized instruments (e.g., sponge 160, scalpel 162, etc.). Theprocedural area may also include a receptacle 116 for used or discardedinstruments or waste in general. In a preferred form, the wastereceptacle 116 includes flaps 116 b that keep the contents of thereceptacle 116 generally covered while new items are not beingdiscarded. In FIG. 1A, the tray 114 and receptacle 116 are covered withsterilized drapes 118 to ensure that a sterile procedural environment isoffered prior to and during the procedure.

The system or apparatus 100 will also preferably include instrumentmarkers 180 and zone markers 190 which the system or apparatus 100 canuse to identify an instrument and zone of the procedural area,respectively. The instrument and zone markers 180, 190 may take the formof any machine detectable or readable marker, such as bar codes, RFIDsensors, alpha sequential markings, numeric sequential markings,alpha-numeric sequential markings, or just comprise a machine detectableimage or shape. For example, in some forms, the instrument markerincludes a bar code identifying the instrument and/or containinginformation about the instrument, such as a UPC, EAN, GTIN or othertrade identification for identifying an item. In FIG. 1A, the instrumentmarkers 180 are two- or three-dimensional (2D, 3D) hydrophobic barcodesthat are preferably angle and/or orientation agnostic (meaning they canbe read from any angle and/or orientation). In some forms, however, theinstrument markers may only be detectable at angles that are between±30° off normal (or from normal). In other forms, the instrument markers180 are readable by system 100 over a range of angles that are at leastbetween ±30° off normal (and preferably larger ranges of angles). In theform illustrated, the markers 180 are 3D markers that wrap around theinstrument so that the system or apparatus 100 is capable of reading themarker 180 regardless of position or orientation (e.g., it is angleagnostic).

In a preferred form, the system or apparatus 100 will also utilize amarker that is also human friendly and not just computer detectable orreadable. For example, the instrument or item markers 160 a, 162 a, 164a and 166 a will also include a simplistic marking scheme that a humancan also follow along and track instruments as a way of double checkingand/or providing redundancy for the system or apparatus 100. In someforms, the markers may include an easy to follow sequential pattern sothat a user can easily double check the instruments/items to confirm allare accounted for and can easily identify which is missing (if any). Forexample, markers may include a simple three letter visual que (e.g.,AAA, AAB, AAC, AAD, etc.), that a human can follow to perform aredundant manual check to ensure all instruments/items are accounted forat the end of the procedure. This easy coded scheme can be based onalpha characters, numeric numbers, alpha-numeric combinations, orsymbols (symbology). The latter could consist of simple imagery (visualsymbolism) such as images of different fruits (e.g., apple, pear,banana, etc.), different shapes (e.g., circle, square, triangle, etc.),different images of commonly understood items (e.g., house, dog, car,different color crayons, etc.).

In a preferred form, the system or apparatus discussed herein willincorporate and embrace redundancy. For example, in preferred forms, thesystem or apparatus will include at least two of the following markingschemes for tracking instruments/items: machine detectable or readablemarker; radio frequency identification (RFID); and/or an easy codedscheme that is readily human recognizable. The RFID markers may beactive or passive RFID, however, in a preferred form, active RFID willbe utilized. A benefit to the use of RFID markers over bar code markersis that they do not need to be within the line of sight for the readerto detect their presence which can be helpful in instances where themarker may not always be readily visible (e.g., medical personnel areholding the instrument in a way that hide or partially hide the marker,drape is folded over at least a portion of the marker, etc.).

In FIGS. 1A-B, the instrument markers 180 are preferably affixed to theinstruments (e.g., sponge 160, scalpel 162). In the form shown, theinstrument markers 180 are labels comprising a substrate with adhesivebacking. Specifically, sponge 160 includes instrument marker label 160a, and scalpel 162 includes instrument marker label 162 a. However, inother forms, the instrument markers 180 may be substrates or materialsfastened to the instruments in a variety of other manners, such as byscrew, bolt, rivet, hook and loop fastener, clasp or clamp, zipperand/or thread. In still other forms, the markers 180 may be bonded,etched, engraved, embossed, carved, molded, stamped, pressed, painted,printed or vapor deposited into/onto the instrument itself, or into/ontothe marker material itself.

In FIG. 1A, the zone markers 190 are preferably made of a machinedetectable indicia and may be used to divide at least portions of theprocedure area into different zones. The zone markers 190 may be made inthe same manner as the instrument markers 180, however, in a preferredform, the zone markers 190 do not need to be as complex as theinstrument markers 180 in order to independently identify numerousinstruments. Rather, they simply need to be machine detectable toidentify the boundary of each zone and distinguish one zone fromanother. In FIG. 1A, the upper surfaces of the perimeter wall of tray114 are lined with a first zone marker 114 a to identify Zone One 120.Similarly, the upper surface of the perimeter walls of waste receptacle116 are lined with another zone marker 116 a to identify Zone Two 130.

In this way, system or apparatus 100 is capable of tracking theinstruments 160, 162 as they are moved from the tray 114 identified asZone One 120 to waste receptacle 116 identified as Zone Two 130. Moreparticularly, system or apparatus 100 and, in particular, controller 112uses camera 110 to track movement of instruments 160, 162 and canreadily identify which zone the instruments 160, 162 are in when medicalpersonnel want to know same.

In FIG. 1B, a slightly different tray 114 is used and is divided upbetween a new or sterile instrument side and a used or discardedinstrument side. Such a tray may be used in situations where theinstruments are not to be discarded (such as when they can be sterilizedagain and reused). In the form illustrated, zone markers 190 are appliedaround the upper perimeter wall and the central dividing wall of thetray to divide the tray 114 into Zone One 120 and Zone Two 130. In thisexemplary embodiment, an additional zone, Zone Three 140, is used toidentify the surgical arena, and another zone, Zone Four 150, is used toidentify an area outside of the other zones and/or an area out of viewof the camera 110. If desired, a waste receptacle, such as wastereceptacle 116, could be added and another zone added for the wastereceptacle by defining its boundaries with another zone marker, however,for simplicity such an additional item and zone is not shown in FIG. 1Bat this time.

Thus, in practice, tray 114 may comprise a surgical kit customized forthe particular medical procedure that is to take place and having zonemarkers 190 that divide the tray up into Zone One 120 and Zone Two 130,with Zone One 120 containing the necessary sterilized instruments forthe intended procedure. The instruments illustrated are sponge 160 withsponge marker 160 a, scalpel 162 with scalpel marker 162 a, forceps 164with scissor/clamp instrument marker 164 a and gauze 166 with gauzemarker 166 a. In operation, system or apparatus 100 utilizes camera 110and controller 112 to track movement of the instruments throughout theprocedure from Zone One 120, Zone Two 130, Zone Three 140 and Zone Four150. Thus, the system or apparatus 100 will track planned movement 1 ofan instrument from Zone One 120 to Zone Three 140 where it will be usedin the operating arena of the procedure area and planned movement 2 ofthe instrument from the surgical arena of Zone Three 140 to the discardor used region of Zone Two 130 on tray 114.

The system or apparatus will also track unplanned movement 3 of aninstrument out of Zone One 120 (sterilized product area) to Zone Four150 (area outside of the sterilized product area 120 or surgical arena140) or unplanned movement 4 of an instrument out of Zone Three 140(surgical arena) to Zone Four 150 (area outside of the surgical arenathat is not one of the defined start or discard zones or is out of theview of camera 110). In a preferred form, the system or apparatus 100includes an alarm 119 that will alert users (e.g., medical personnel) tothe unplanned movement of one of the instruments 160, 162, 164 and/or166. The alarm may be its own standalone component or it may beintegrated into one of the other components of system or apparatus 100.In FIG. 1B, the alarm 119 is illustrated as being located in connectionwith either display 170 or camera 110. Preferably the alarm 119 will atleast be associated with display 170 and will include both audio andvisual components to definitively catch the eye of the user to alertthem to the unplanned movement of at least one of the instruments. Insome forms, the alarm 119 will include at least one of an audible alarm(e.g., audible sound or buzzer), a visual alarm (e.g., flashing light orchange of color to stand out from surrounding portions of the screen,etc.) and/or a tactile or haptic alarm (e.g., a vibration, wobble,etc.), and in a preferred form, it will include all three.

In FIG. 1B, the system or apparatus 100 is configured to signal alarm119 in order to indicate one or more of the following: a medicalinstrument is missing from all of the physical zones 120, 130, 140 and150; a medical instrument is detected in an undesired zone (e.g., ZoneFour 150, a used device approaching Zone One 120, etc.); a medicalinstrument detected in a zone for too long of a time period (or periodof time); and/or a medical instrument moved out of a predetermined orderestablished for the medical personnel involved. The first two examplesimmediately above indicating when alarm 119 should be signaled areclear, however, the latter three examples are a little less clear andshow what can be done by the system or apparatus 100 being used to trackperformance over a plurality of procedures (e.g., based on prior dataindicating best practices for the particular procedure itself, thepreferred order of sequence for particular medical personnel involved inthe instant procedure, etc.). For example, with the information that isgathered by system or apparatus 100 from prior procedures, the system orapparatus may learn or be programmed to understand that a particularinstrument should only remain in a particular zone for a certain amountof time. If the system or apparatus 100 see an instrument in a zone forlonger than the predetermined period of time, the system or apparatus100 may immediately bring this to the attention of the users/medicalpersonnel so that a situation does not occur where this is only noticedat the end of a procedure (perhaps after a patient's operating openingis closed via staple or suture/stitches).

In other examples, by being utilized in multiple procedures, the systemor apparatus 100 may learn or be programmed to know the order that aparticular procedure requires the instruments to be used in or the orderparticular medical personnel using the system or apparatus 100 like toproceed in and can tell when an instrument is taken out of order (or outof proper sequence) as it is being removed from the initial sterilizedzone area of Zone One 120 and can alert medical personnel that an itemis being taken out of the normal order instruments are used either forthis procedure or for this particular medical personnel. In a preferredform, the system or apparatus 100 will detect movement of the instrumentout of sequence while the instrument is still within the bounds of ZoneOne 120 and cause the return of the item without concern that it hasbeen contaminated or is no longer sterile.

In still other forms, the system or apparatus 100 is capable of learningor being programmed to know what portion of the patient the procedureshould involve and can monitor where the instruments are being taken andalert the medical personnel if they appear to be going to a portion ofthe patient's body that they should not be near. For example, if theprocedure is an appendectomy and the system or apparatus 100 detectsthat instruments are being moved to the patient's left side (instead ofright where the appendix is at) or if they are being moved toward thepatient's shoulder, head, foot, etc., the system or apparatus 100 canalert the medical personnel so that a check can be made to ensure theproper procedure is being performed on this patient, that properprocedural steps are being followed, etc. In some forms, the system orapparatus 100 are synched with electronic medical records and is capableof knowing exactly what procedure is to be performed on the particularpatient at hand and can alert the medical personnel if it appears to betaking action that does not correspond with the records provided forthis patient (e.g., alerting personnel if they appear to be working on aright appendage when the records state that work is to be done on a leftappendage, etc.). As should be understood by these examples, the systemor apparatus 100 not only has the ability to make procedures moreefficient and prevent errors associated with retained objects within apatient's body, but it also has the ability to double check and preventerroneous procedures from being performed.

The examples immediately above are examples of artificial intelligencethat the system or apparatus 100 can develop (e.g., learn or beprogrammed to know) over time and are referred to herein as proceduralscience. With this procedural science, system or apparatus 100 canassist medical personnel to perform procedures even more efficiently andcan prevent undesirable conditions from presenting themselves orremaining present for long without at least alerting the medicalpersonnel to same. That is not to say that the medical personnel mayhave a reason for the anomaly or atypical procedural tactics, but thesystem or apparatus 100 is at least capable of alerting the medicalpersonnel to this issue and they can either correct the issue or usesome form of actuator to at least temporarily clear or suspend the alarmcondition. For example, an override switch may be included with systemor apparatus 10. This could be a mechanical switch (e.g., push button,toggle switch, etc.) or it may be a software switch (e.g., an on-screenbutton, audible command, etc.). In a preferred form, however, the systemor apparatus 100 will be configured to only allow the override to be setfor a period of time and will then initiate the alarm again unless thealarm condition is no longer present. The actuation of such an overrideor suspend actuator will also preferably result in the system orapparatus 100 displaying on the display further information about theitem that triggered the alarm condition (e.g., last location, position,velocity or speed of travel, vector or direction of travel and/orinstrument marker data such as what marker data the medical personnelshould be looking for in order to assist them in finding the missingitem). In other forms, however, no override may be offered and thesystem 100 may prevent the procedure from proceeding until the missingitem is located (e.g., such as by preventing the medical instrumentretention alert system alarm from being disabled, preventing othersystems from being operable until the missing item is found, etc.).

In addition, the system or apparatus 100 may include an active locatorassistant that helps the user locate the missing item. For example, insome forms the active locator assistant projects a beam of light, suchas a laser, to the last known location of the missing item. Further, thesystem or apparatus will preferably continuously track eachinstrument/item and display on the display at least two of the x, yand/or z coordinates for the instrument/item, as well as specific datarelating to both the spatial movement and position of theinstrument/item. In some forms, the data provided will also include thezone the instrument/item is located within. Thus, system or apparatus100 is capable of providing improved predictive analysis of where amissing instrument/item is likely to be should one go missing.

The system or apparatus 100 will include a user interface that the useroperates to interact with the system or apparatus 100. Ideally all ofthe above mentioned actuators will be located on or accessible throughthe user interface. In the form illustrated, the display 170 includes atouch screen with a user interface including a button to locate missinginstruments/items. In a preferred form, the user interface of display170 will further include a button for activating the active locatorassistant and another button for the alarm override. In alternate forms,however, the display and/or user interface may actually be app based andaccessible through a smart phone or tablet. The system or apparatus 100may be configured to display the buttons mentioned above at all times,however, in alternate forms, the buttons may only appear after an itemhas gone missing or may be accessed through an operating system havingdrop-down or cascading menus or windows. In the form illustrated, theuser interface on display 170 will also provide an image of the missinginstrument/item and allow a user to replay a clip illustrating theinstrument/item prior to it going missing. In a preferred form, thesystem or apparatus 100 will capture and retain all video for theprocedure so that the user will be able to determine how far back theywant to go or how long of a clip they want to view of the missinginstrument/item. This DVR like feature may be configured to retain thevideo of every procedure or it may automatically delete such video aftera set period of time unless the user has selected or saved the video forretention beyond the date/time it would be deleted or overwritten bydefault practices. The system or apparatus 100 may store video data intolocal or remote memory storage that a user can access for replay toeither review a procedure or track any of the plurality of medicalinstrument used during the procedure. This video data can be used alongwith the other procedural data collected (i.e., the procedural science)and utilized to critique medical personnel performance, identifymistakes, and/or identify best practices.

In addition to the above, the procedural science gained by repeated useof system or apparatus 100 can be paired with additional data relatingto the procedure or patient (e.g., follow-up date regarding the patientsuch as if they had any setbacks, if they had to be treated for certainissues down the road that may have resulted from the way the procedurewas performed due to it being a common issue for those going through thesame procedure, etc.) to help identify best practices, particularmedical personnel that excel in a particular procedure, etc. Forexample, it is now known that early appendectomies performed vialaparoscopy with one incision going through the umbilical cord haveresulted in a greater risk of umbilical hernias for these patients. Itis possible that system or apparatus 100 would have been able to detectthat sooner by pairing the data it collects from being involved innumerous procedures and pairing that with post procedure data relatingto these patients.

Turning now to FIGS. 2A-E, exemplary screen displays of a system orapparatus in accordance with embodiments of the present invention areillustrated therein. As mentioned above, items similar to thosediscussed above with respect to FIGS. 1A-B will utilize the same lattertwo digit reference numeral, but have the prefix “2” instead of “1” todistinguish one embodiment from others. Thus, in the form illustrated inFIGS. 2A-E, the display is identified via reference numeral 270 and issimilar to the exemplary displays discussed above with respect todisplay 170 in FIGS. 1A-B. In FIGS. 2A-E, display 270 illustrates adisplay screen that has camera images 271 located in an upper portion ofthe display 270 and the following camera images of the procedural areaare illustrated (from left to right): tray camera image 271 a, surgicalarena camera image 271 b, missing Zone Four tray camera image 271 c anddiscard camera image 271 d.

Below camera images 271 on display 270 are fields relating to thevarious zones being monitored by system or apparatus 200. From left toright, the display 270 illustrates tray Zone One field data 272,surgical arena Zone Three field data 273, missing Zone Four field data274 and discard Zone Two field data 275. Although the camera images 271are aligned with the specific zones that correlate with those cameraimages, it should be understood that in alternate embodiments, this maybe arranged differently if desired. For example, the camera images couldbe arranged in a different order than the columns containing the zonedata or zone information portion of the display (e.g., 272, 273, 274,275). In other forms, the camera images may be aligned with theirrespective column zone data, but may be a different order than thatdepicted in FIGS. 2A-E. For example, the system 200 may be configured toallow the user to select what order these items appear or are presentedon display 270. In still other forms, not all camera pictures need bedisplayed and/or the system can be configured to allow the user toselect which pictures or column data appears on display 270 and in whatorder or position in order to allow the user to customize the layout tohis/her preference or need. For example, it may be desirable to onlydisplay one of the zones (e.g., surgical arena) during the procedure andreserve the other images should a need arise to locate a missing item.

In a preferred form of operation, FIG. 2A illustrates the appearance ofdisplay 270 at the start of a medical procedure where all of theinstruments (e.g., forceps 264, scalpel 262, sponge 260 and gauze 266)are located on tray 214 (illustrated in tray camera image 271 a) areidentified as being in the tray 214 as illustrated by the tray statusfield 272. In FIG. 2B, the gauze 266, scalpel 262 and forceps 264 havebeen moved from the tray 214 to the procedure area or arena (or surgicalarea/arena) zone 240 as illustrated in tray camera image 271 a andsurgical arena image 271 b. In a preferred form, as items or instrumentsare moved from one zone to another, the display 270 will highlight thoseitems or instruments in a color, such as the red or pink colorillustrated in surgical arena zone 273 in FIG. 2C to make it clear tousers that these items have recently moved into this zone. The system200 could be configured to keep the items highlighted in color theentire time they are outside of the tray image 271 a, or it could beconfigured to simply highlight them in a color once when they move to anew camera image or field. In a preferred embodiment, the items will behighlighted in color and blink in column 273 while the item is detectedin the surgery camera image 271 b and stop blinking when returned to thetray image 271 a/column 272 or the discard image 271 d/column 275. Thejagged lines (or lightning bolts) under column 273 in FIG. 2C are meantto represent the flashing of the red or pink color for the itemsdetected in the surgery camera image 271 b If an instrument/item isremoved from one of the acceptable zones (i.e., tray Zone One 220,procedure Zone Three 240 or discard Zone Two 230), such as movement ofthe instrument/item to missing Zone Four 250, then the system orapparatus 200 will display the missing item under missing item field 274as illustrated in FIG. 2D. As mentioned above, in a preferredembodiment, this instrument/item will be highlighted in color to drawattention to same from the user, but it will also preferably beaccompanied by an alarm alerting the user to the fact an item ismissing. In the form illustrated, the alarm sounds an audible beep ortone followed by an audible announcement announcing the name of theinstrument/item missing. In the form illustrated in FIG. 2D, the jaggedlines represent that the highlighted color flashes to draw attention tothe missing item and the arced lines represent the audible alarm oralert that will preferably play. In a preferred form, the items arehighlighted in a flash of color once when moved from the tray field 272to the procedure area 273, but are repeated highlighted in flashingcolor in missing field 274 if they have gone missing. In alternateforms, more or less flashing of color may be used or none at all. Forexample, in some alternate forms, the highlighting of the items in colormay be reserved for only when those items have gone missing and show-upin field 274.

Also as mentioned above, the system or apparatus 200 will preferably beequipped with an override actuator that the user may actuate if the itemhas been intentionally moved out of the main zones. Ideally, the alarmwill only be delayed by a period of time (which may selected by the useror, alternatively, may be predetermined by system or apparatus 200) sothat the override operates more like an alarm clock's snooze button,rather than completely disabling the alarm. However, in other forms, thesystem or apparatus 200 may be provided with an override that completelyoverrides the alarm or it may be provided without an override. Giventhat the system's alarm will preferably be using audible alerts, inpreferred forms the system or apparatus 200 will include an override(e.g., snooze, sleep or mute actuator) in order to prevent the audiblealarm from creating an unnecessary commotion in the procedure area.

Once all instruments/items are returned to the discard Zone Two, thedisplay 270 will illustrate same in discard Zone Two field 275 and allalarms (if any) will be disabled as illustrated in FIG. 2E. Although theembodiment illustrated in FIGS. 2A-E, illustrates that all theinstruments/items are returned to a single zone or location, such asdiscard Zone Two 230 as illustrated in camera image 271 d and discardzone field 275, it should be understood that in alternate embodimentsinstruments/items may be returned to one or more zones or locations asdesired. For example, in embodiments where a tray with a discard portionis provided for items that can be sterilized and reused and a trashreceptacle is provided for items that cannot be reused, it may bedesirable to have system or apparatus 200 configured to direct users toreturn the reusable items to the discard portion of the tray and thenon-reusable portions to the waste receptacle. If the user fails to dothis, the system or apparatus 200 could be configured to notify the userof this and/or trigger an alarm until such steps are complied with.

In a preferred form, the system or apparatus 200 will be able to displayon the display 270 additional information relating to any instrument andcan be configured to do this at all times or only during alarmconditions. For example, the tracking system or apparatus makes itpossible to not only identify what zone a missing instrument was lastin, but it will preferably also be able to provide x, y and zcoordinates for same. Other information it may provide include beyondlocation or position include velocity or speed of travel, vector ordirection of travel, telemetry and/or instrument marker data. The system200 will preferably be able to provide x, y, z coordinates for itemswhile the items are in use (even if not missing) and provide time stampdata or time tracking information for each item. This data may be usefulfor training of medical professionals, such as by showing howinstruments were used and/or for how long in procedures that went well,those that did not go well or as desired, or in a comparison andcontrast between those that went well and those that did not go well oras desired.

In FIGS. 2A-E, the video images depicted in image row 271 will showrealtime imagery of the specific areas or zones they are monitoring. Forexample, in FIG. 2A, all instruments for the procedure being performedare shown in the tray in image 271 a and tray field 272. Once theprocedure has begun, the items that are moved to the procedural area areshown in surgery image 271 b with those remaining in the tray stillbeing shown in tray image 271 a as illustrated in FIG. 2B. The initialmovement of the items (e.g., from the tray to the procedural area) isemphasized by highlighting the items that were or are being moved incolor as illustrated in FIG. 2C. In a preferred form, these items willcontinue to blink in the highlighted color while in use during theprocedure, however, in alternate forms, the highlighted blinking mayonly be used upon the initial movement of the item away from itsstarting position. Once the items are returned to the desired discardarea (e.g., tray, waste receptacle, etc.), the items will be shown inthe procedure conclusion field 275 as illustrated in FIG. 2E without anyhighlighting via color. In a preferred form, an audible tone orannouncement will also be made to confirm to the medical personnel thatthe item has properly been recorded in or detected in the discard area.Again, while the camera image 271 d in FIG. 2E shows all items returnedto the discard area, it should be understood that in other forms of theinvention some items may be shown returned to a discard area or tray forlater sterilization while others are confirmed having been thrown awayin an appropriate receptacle, such as by detecting the item within thezone markers delineating the waste receptacle opening and/or notdetecting it leave that delineated boundary.

Should an item go missing during the procedure, such as out of the sightor zone of the tray camera image 271 a, procedural camera image 271 band/or discard camera image 271 d, the missing item will be moved tomissing field 274 and preferably highlighted in a flashing color withthe audible alert being sounded for same as illustrated in FIG. 2D. In apreferred form, the system will announce the item that is missing (e.g.,“Missing forceps 1”, “missing sponge 1”, etc.). In a preferred form, themissing item camera image 271 c will be setup to show where the missingitem is if visible. For example, in FIG. 2D, the sponge 260 is shown ashaving gone missing from the image areas of 271 a, 271 b and 271 d, butis illustrated down at the foot of the patient in missing item cameraimage 271 c. In some forms, the system will be setup to automaticallyreplay a video clip in missing item camera image 271 c showing where themissing item was last seen or detected right before it went missing andthe data illustrated in missing field 274 will display the x, y, zcoordinate and time data for the item's last detected location andpreferably the vector data (e.g., velocity and trajectory/directiondata) of the item at that time to give an idea of where it may be. Inother forms, the system may require the user to select an item (e.g.,physically depress or actuate a button, touch a software button such asGUI interface or icon on display 270, etc.) to get the video clip toplay and simply will display the missing item camera image 271 c showinga larger view or zoomed out view of the room within which the procedureis taking place or surrounding environment around where the procedure istaking place beyond those areas depicted in the other camera images 271a, 271 b and 271 d.

FIG. 3 is a flow chart illustrating one manner in which the system orapparatus may be configured to run. In a preferred form, the controllerof system or apparatus 300 would include a process configured to performthe following steps or process. The process would start at step 305 aand use the camera to detect machine detectable data (e.g., read machinereadable information) in tray Zone One 305 b. Then the system orapparatus 300 would detect machine detectable data (e.g., machinereadable information) in discard Zone Two 305 c. Next, in step 305 d,the system or apparatus 300 would determine if a change in aninstrument/item location has occurred. If not, the program would returnto start 305 a. If so, the system or apparatus 300 would update thedisplay to indicate the detected change in step 305 e. As mentionedabove, in a preferred form, the system or apparatus 300 will actuallyhighlight the instrument/item once it has changed from one zone toanother in order to make it easy for the user to see the change that hastaken place.

In FIGS. 4A-C another exemplary embodiment in accordance with theinvention is illustrated showing a system or apparatus 400 comprising aprocedure prep table 401, having a first shelf 401 a, second shelf 401b, camera 410 and waste receptacle 416. In the form illustrated the preptable 401 is shown as a stationary table that rests on four legs,however, it should be understood that in alternate embodiments the preptable 401 could be a mobile table, such as one having casters or wheelson the bottom of each leg (preferably lockable). In the form shown, thesystem or apparatus 400 includes a prep table drape 402 that issterilized and capable of being unfolded to cover all prep tablesurfaces to provide a sterilized surface upon which to restequipment/items to be used during the medical procedure. In FIG. 4A, theprep table drape 402 is shown in a folded state as it appears onceremoved from its initial packaging. In a preferred form, the drape 402includes integral instructions 402 a explaining to a user how the drape402 is to be unfolded to cover all surfaces of the prep table 401 andsurrounding areas. In FIG. 4B, the drape 402 is partially unfolded overmost of the upper surfaces of the lower shelf 401 a and waste receptacle416. The drape 402 includes fabric portions 402 b (e.g., pockets, handslots, etc.) that the user may use to assist him/her in unfolding thedrape 402 over the table 401. In FIG. 4C, the drape 402 is unfoldedfully over the second shelf 401 b so that the upper surfaces of shelf401 are fully covered by drape 402. Further details regarding the prepor back-table drape are disclosed in U.S. Patent Application PublicationNo. 2013/0186413A1, entitled Surgical Drape and System having a Barrierfor Preventing the Start of a Surgical Procedure and Methods for UsingSame, published to Applicant on Jul. 25, 2013 and U.S. PatentApplication Publication No. 2014/0261457A1, entitled Apparatus andMethod Pertaining to a Multi-Tier Back-Table Drape, published toApplicant on Sep. 18, 2014, which are incorporated herein by referencein their entirety. In a preferred form, however, the drape 402 includesintegral zone markers identifying and distinguishing between the firstzone (e.g. tray or prep table Zone One 420) and the second zone (e.g.,discard zone or waste receptacle Zone Two 430), which the camera 410 candetect in order to track instruments/items as they are moved from onezone to another. While the embodiment illustrated in FIGS. 4A-Ccomprises two zones, it should be understood that the system orapparatus 400 could be configured with additional zones similar to thosediscussed above (e.g., surgical arena zone, missing zone, etc.).

Turning now to FIG. 5, there is illustrated a procedural kit 504 inaccordance with other embodiments of the invention. In a preferred form,the kit 504 is customized for a particular procedure and containsinstruments/items that have instrument markers (like those discussedabove) for use with systems or apparatus like those disclosed herein.The instruments are wrapped in a drape 502 which can be removed from thekit 504 and opened similar to drape 402 discussed with respect to FIGS.4A-C. Once removed, the drape 502 can be unfolded as instructed and thesterilized instruments will be positioned on the prep zone of the drape,so that they tracking system or apparatus the kit 504 is used with canbegin tracking movement of the instruments from zone to zone. Asillustrated in FIG. 5, the kit preferably has an itemized list 504 a ofthe kit contents on the outside of the kit 504 and has a handle 504 b bywhich the kit can be carried and transported. Since the kit can bemodified based on the particular procedure, there may be extra itemsthat are not included in the kit and this can be denoted by leaving thequantity column blank on listing 504 a for that item. Similarly, itemsthat are not used during the medical procedure can be noted on the outerpackaging that they were not used as a means for confirming that theinstrument/item has not been used and, thus, is not missing. Additionaldetails on such customized kits can be found in U.S. Patent ApplicationPublication No. 2014/0021087A1, entitled Custom Procedure Kit, publishedto Applicant on Jan. 23, 2014, which is incorporated herein by referencein its entirety.

FIG. 6 illustrates an exemplary patient support 607 and drape 606 inaccordance with other embodiments of the invention. The patient support607 may be a number of different patient support items, such as a bed,gurney, exam table, chair, wheelchair or the like. In the form shown,support 607 is an operating table and includes computer detectableindicia, such as zone markers 607 a which tracking systems or apparatuslike those discussed above can detect and use to identify the operatingtable boundary as a zone. For example, the tracking system or apparatusmay use the markers 607 a to define the operating arena zone 640 whichis similar to Zone Three 140 discussed above in FIG. 1B. In some forms,the markers 607 a will be integrated into the support 607 so thatmedical personnel do not have to worry about disturbing or damagingthese items when moving patients on and off the support 607. Forexample, the markers 607 a may be molded into the surface of the support607. In other forms, however, the zone markers 607 a may be attached tothe support 607 by different means (e.g., fasteners such as screws,bolts, rivets, clasps, clamps, adhesives, hook and loop connectors,thread, welds, etc.). The zone markers 607 a can be connected to support607 so that they can be removed and replaced, or alternatively, apermanent connection may be used between the marker 607 a and support607.

In addition to the patient support 607 having zone markers 607 a, thepatient drape 606 illustrated in FIG. 6 may also include computerdetectable indicia such as zone markers 606 a. In a preferred form,drape zone markers 606 a are positioned around the surgical site so thattracking systems or apparatus like those discussed herein can detect thedrape markers 606 a and use them to identify a surgical site zone 642which is located within the surgical arena 640. As with the patientsupport markers 607 a, patient drape markers 606 a may be connected tothe drape 606 in a variety of ways and may either be connected in amanner that makes the markers 606 a permanently affixed to drape 606 oralternatively in a manner that allows them to be removably attached. Insome instance, the drape 606 is designed to allow the drape markers 606a to be removed and reattached in a manner desired by the medicalpersonnel so that the medical personnel can customize the size and shapeof the surgical site zone 642 to the specific patient and/or procedurebeing performed. For example, in some forms, the drape 606 and drapemarkers 606 a are connectable to one another via a releasable adhesiveor a hook and loop type connection so that the markers 606 a can bereadily moved and/or repositioned as desired. This type of configurationmay allow a generic patient drape to be used rather than requiringspecific drapes for specific procedures because the medical personnelcan position the drape markers 606 a wherever they need to for theprocedure being performed. However, in other instances, it may bedesirable to require specific drapes for specific procedures as thishelps ensure the procedure will be performed correctly (e.g., helpsensure the procedure will be performed in the correct spot, on thecorrect appendage, on the correct side, etc.).

The ability to define a smaller surgical site zone 642 within theoperating arena zone 640 gives the tracking systems or apparatusdiscussed herein further functionality and ability to track items andalert medical personnel if an instrument/item is approaching thesurgical site zone 642 that should not be approaching that zone. Forexample, if an already used and discarded instrument is picked-up andbrought back toward the surgical site zone 642 and shouldn't be, thetracking systems or apparatus can issue an alarm to alert medicalpersonnel to stop this from happening. Having such extra zones can alsoprovide more surgical science data that can be collected and studied tofurther improve procedures and define best practices. For example, extrazones allow further tracking of what medical personnel did throughout aprocedure and, thus, provides greater data to study situations that goright and those that go wrong.

In addition to the systems and apparatus discussed herein, it should beunderstood that numerous methods are also disclosed herein. For example,other uses can be made of the data collected via such tracking systemsand apparatus. In some instances, the data may be maintained in adatabase form and access to same may be provided to others either forfree or for fee. Entities that likely would want access to such datainclude insurers, medical schools, institutions performing evaluationsof their own staff and procedures, researchers, suppliers of medicalequipment used in such procedures, and the like. In some forms, insurersmay even utilize the data collected via these systems or apparatus tohelp set insurance premiums and to help setup educational presentationsto teach their clients best practices to minimize risk in performingvarious procedures.

In another example, a method for confirming proper medical procedure isdisclosed herein which comprises providing a medical instrument trackingsystem for continuous tracking of medical instruments during a medicalprocedure, continuously tracking the medical instruments during themedical procedure, and alerting medical personnel when the medicalinstrument tracking system detects a medical instrument being usedincongruous to a predetermined order of use for the medical procedure.

In still another example, a method of utilizing surgical analytics isdisclosed herein comprising providing a medical procedure trackingsystem for continuous tracking of medical procedure analytics,continuously tracking the medical procedure analytics, utilizing themedical procedure analytics to perform at least one of the followingtasks: (a) establishing a preferred medical procedure process to befollowed for a specific medical procedure; (b) identifying a preferredprocedural course of action for a patient based on specific detailsrelating to that particular patient; (c) customizing a medical procedurekit for a particular medical procedure; (d) customizing a medicalprocedure kit for a specific patient; and/or (e) identifying aparticular medical personnel's preferred medical procedure process andalerting other medical personnel to same.

Thus, it should be understood that numerous methods, systems andapparatus are disclosed herein for improving medical procedures andtracking medical instruments (or items). For example, an apparatus fortracking medical instruments throughout a procedure is disclosed hereinhaving a single camera for tracking movement and/or detecting positionof a plurality of medical instruments during a medical procedure as atleast one of the plurality of medical instruments is moved betweenmultiple zones at least including a first prep zone and a secondprocedure zone, a controller connected to and collecting images from thecamera, and a display in electrical communication with the controllerand/or the camera for displaying medical instrument data pertaining tothe movement and/or position of the plurality of medical instruments.

In some forms, the apparatus for tracking medical instruments throughouta procedure includes an alarm for indicating at least one of thefollowing alarm conditions: a medical instrument missing from all of thephysical zones; a medical instrument detected in an undesired zone; amedical instrument detected in a zone for too long of a time period; amedical instrument moved out of a predetermined order established forthe medical procedure involved; and/or a medical instrument moved out ofa predetermined order established for the medical personnel involved.The alarm may be at least one of: an audible alarm; a visual alarm;and/or a tactile or haptic alarm. In a preferred form, the alarm is bothan audible alarm and a visual alarm, the audible alarm being a speakeremitting an announcement announcing that at least one of the pluralityof medical instruments has gone missing and the visual alarm is aflashing indicator on the display identifying the at least one of theplurality of medical instruments that has gone missing.

The systems or apparatus disclosed herein may include a controllerand/or display having a user interface for suspending or delaying thealarm. In a preferred form, the user interface not only suspends ordelays the alarm, but causes the display to display additionalinformation relating to the alarm condition including at least one of amedical instrument position, location, velocity or speed of travel,vector or direction of travel, telemetry and/or instrument marker data.

The systems or apparatus herein also include a plurality of medicalinstruments each having an instrument marker and the controller of thesystem or apparatus is capable of tracking movement and/or detectingposition of the plurality of medical instruments from their respectiveinstrument markers. The instrument markers may include a machinereadable marking comprising at least one of: a bar code; a RFID sensor;a UPC, EAN or GTIN; an alpha, numeric or alpha-numeric sequentialmarking; and/or an easy coding scheme that is readily identifiable by ahuman for redundant checking purposes. In some forms, the easy codingscheme includes a sequence of easily followed numbers, letters, and/orsymbols (e.g., 1, 2, 3, 4 . . . ; 0001, 0010, 0100, 1000 . . . ; a, b,c, d . . . ; aaaa, aaab, aaac, aaad . . . ; red house, orange house,yellow house, green house . . . ; hand with 1 finger raise, hand with 2fingers raise, hand with 3 fingers raise, hand with four fingers raised. . . ; etc.).

In some forms, the instrument marker is a two-dimensional (2D) barcodeor a three-dimensional (3D) barcode machine readable from first andsecond angles with the first and second angles being greater than thirtydegrees (30°) apart. In a preferred form, the instrument marker andcontroller interact as an orientation, position or angle agnostic systemthat is capable of tracking movement and/or detecting position of theplurality of medical instruments via the instrument marker regardless ofwhat orientation, position or angle each medical instrument orinstrument marker is in at any given time. In other forms, theinstrument marker is a two-dimensional (2D) barcode or athree-dimensional (3D) barcode machine readable from an angle that is atleast plus or minus thirty degrees (±30°) from normal to the instrumentmarker. Preferably, the instrument marker is hydrophobic to improvemachine readability of the instrument marker (e.g., by beinghydrophobic, the marker is self-clearing to ensure it will be detectableby the tracking system or apparatus). In still other forms, theinstrument marker is formed on the medical instrument via etching,engraving, embossing, carving, molding, stamping, pressing, painting,printing, or vapor deposition.

In addition to instrument markers, there are disclosed herein machinedetectable zone markers for delineating physical zones in the procedurearea. In some forms, the machine detectable zone markers have first andsecond sides, with machine readable information on the first side and afastener on the second side for fastening the machine detectable zonemarkers to a surface, the fastener including at least one of: anadhesive; a hook or loop fastener portion; a clasp or clamp; a zipper;and/or a thread. In preferred forms, the machine detectable zone markersare machine readable markings and hydrophobic to improve machinereadability of the zone markers. The machine detectable zone markers mayinclude a machine readable marking having at least one of: a bar code; aRFID sensor; a UPC, EAN or GTIN; an alpha, numeric or alpha-numericsequential marking and/or an easy coding scheme that is readilyidentifiable by a human for redundant checking purposes. In some forms,the zone markers are formed on medical drapes or coverings for at leastone of a surgical instrument table, patient, operating table or patientsupport, surgical equipment, and/or waste container.

The system or apparatus preferably includes a camera that bothcontinually tracks movement and detects position of the plurality ofmedical instruments and the system or apparatus has a display thatdisplays specific data pertaining to both the spatial movement andposition of the plurality of medical instruments. In some forms, thespecific data pertaining to spatial movement includes tracking at leasttwo of a x coordinate, a y coordinate and/or a z coordinate of the atleast one of the plurality of medical instruments and the specific datapertaining to location includes an identification of what zone the atleast one of the plurality of medical instruments is currently located.The controller may use the camera to track medical instrument dataincluding one or more of location, velocity or speed of travel, vectoror direction of travel, and/or telemetry. In preferred forms, thecontroller uses the medical instrument data to provide an improvedpredictive analysis of where a missing medical instrument is likely tobe should one of the plurality of medical instruments go missing.

The systems or apparatus may include a first zone where instruments areinitially positioned prior to procedure and a second zone whereinstruments are positioned post procedure. In some forms, a thirddiscard zone may also be included and tracked via the system orapparatus.

The system or apparatus will also include a user interface for locatinga missing medical instrument from the plurality of medical instruments.Preferably, the user interface is at least one graphical user interfacelocated on the display that, when actuated, the controller displays onthe display an image or video of the missing medical instrument prior tothe missing medical instrument going missing to assist with locating themissing medical instrument. The controller may be configured such that asingle actuation of the at least one graphical user interface allowsvideo of the missing medical instrument to be pulled-up on the displayand queued up to a period of time at or near when the missing medicalinstrument went missing which a user can review and replay as desired.In some forms, the system or apparatus stores video into local or remotememory storage that a user can access for replay to either review aprocedure or track any of the plurality of medical instruments usedduring the procedure.

In some forms, the system or apparatus is configured to be a medicalinstrument retention alert system and includes an alarm for alertingmedical personnel when a medical instrument from the plurality ofmedical instruments has not been accounted for or is still detected inthe procedure zone. If desired, the controller may further disable theapparatus from being used for any other function until the medicalinstrument from the plurality of medical instruments has been accountedfor or removed from the procedure zone.

In other embodiments disclosed herein, a retained object system fortracking medical instruments throughout a procedure is disclosed having:a camera for monitoring a plurality of physical regions and continuouslytracking movement or detecting position of a plurality of medicalinstruments throughout a medical procedure as at least some of theplurality of medical instruments are moved between physical regions atleast including a first pre-procedure region, a second procedure regionand third post-procedure region; a computer connected to the camera andcollecting images from the camera; and a display in electricalcommunication with the computer and/or camera for displaying medicalinstrument data pertaining to the movement or position of the pluralityof medical instruments as well as images of the physical regions.

In yet other embodiments, an apparatus for tracking medical instrumentsis disclosed herein having: a medical tracking device having a camera, adisplay and a control circuit with a non-transitory computer readablememory storing a set of instructions executable by the control circuitand configured to cause the control circuit to perform the steps of: (a)continuously tracking at least one of a plurality of medical instrumentsvia the camera; and (b) automatically updating the display with currentinformation regarding the position or location of the at least one of aplurality of medical instruments.

In still further embodiments, procedure drape kit is disclosed having asurgical drape having instructions for unfolding the drape in apreferred order of steps, and markers connected to the surgical drape todefine at least one zone, with the at least one zone being at least oneof a pre-surgical procedure zone, a surgical procedure zone, apost-surgical procedure zone.

In other embodiments, a procedure prep table is disclosed hereincomprising a table having a pre-procedure area and a post-procedurearea, and markers defining a general boundary of the pre-procedure areaand the post-procedure area so that a medical instrument tracking devicecan track medical instruments as medical instruments are passing fromthe pre-procedure area to the post-procedure area.

In still other embodiments, a patient support is disclosed herein havinga patient support having a patient support area, and markers connectedto the patient support for defining a general boundary of the patientsupport area so that a medical instrument tracking device can trackmedical instruments as the medical instruments pass in and out of thepatient support area.

In other embodiments, an apparatus for monitoring medical procedures andtracking the equipment used therein is disclosed herein comprising: acamera for creating images or video of a medical procedure and trackingthe equipment used therein; a controller coupled to the camera forcollecting the images or video from the camera and storing the collectedimages or video either in local memory storage or remote memory storage;and a display coupled to the controller for displaying the collectedimages or video from the camera and having a user interface that allowsa user to review the collected images or video to monitor at least aportion of the medical procedure or the tracked equipment used therein.

In some forms, the user interface includes features for allowing theuser to rewind, fast-forward, play and pause the collected images orvideo. The collected images or video may be stored on remote memorystorage accessible via a network, and the apparatus may further includea remote display device located out of the vicinity of the camera that auser can use to access the collected images or video on the remotememory storage via the network to monitor at least a portion of themedical procedure or the tracked equipment used therein.

In yet other embodiments, an item tracking system is disclosed hereinhaving a plurality of items, a camera for tracking the plurality ofitems, and a plurality of item markers each positioned on one of theplurality of items to allow the plurality of items to be tracked, theplurality of item markers and camera operating as an orientationagnostic system that allows the plurality of items to be trackedregardless of what position or orientation the plurality of items are inat any given time during a time period that the plurality of items arebeing tracked by the item tracking system.

In some forms, the item tracking apparatus may include a controller thatuses the camera to track item data including one or more of location,velocity or speed of travel, vector or direction of travel, and/ortelemetry. The controller may use the item data to provide an improvedpredictive analysis of where a missing item is likely to be should oneof the plurality of items go missing.

This detailed description refers to specific examples in the drawingsand illustrations. These examples are described in sufficient detail toenable those skilled in the art to practice the inventive subjectmatter. These examples also serve to illustrate how the inventivesubject matter can be applied to various purposes or embodiments. Otherembodiments are included within the inventive subject matter, aslogical, mechanical, electrical, and other changes can be made to theexample embodiments described herein. Features of various embodimentsdescribed herein, however essential to the example embodiments in whichthey are incorporated, do not limit the inventive subject matter as awhole, and any reference to the invention, its elements, operation, andapplication are not limiting as a whole, but serve only to define theseexample embodiments. This detailed description does not, therefore,limit embodiments of the invention, which are defined only by theappended claims. Each of the embodiments described herein arecontemplated as falling within the inventive subject matter, which isset forth in the following claims. Further, it should be understood thatfeatures of one embodiment described herein may be combined withfeatures of other embodiments described herein in order to develop yetfurther embodiments and such further embodiments are contemplated withinthis disclosure.

What is claimed is:
 1. An apparatus for tracking medical instrumentsthroughout a procedure comprising: a single camera for tracking movementand detecting position of a plurality of medical instruments during amedical procedure as at least one of the plurality of medicalinstruments is moved between multiple zones at least including a firstprep zone and a second procedure zone; a controller connected to andcollecting images from the camera; a display in electrical communicationwith the controller and/or the camera for displaying medical instrumentdata pertaining to the movement and/or position of the plurality ofmedical instruments; and wherein the plurality of medical instrumentseach have an instrument marker and the controller is capable of trackingmovement and detecting position of the plurality of medical instrumentsfrom their respective instrument markers, the instrument marker is atwo-dimensional (2D) barcode or a three-dimensional (3D) barcode machinereadable from first and second angles with the first and second anglesbeing greater than thirty degrees (30°) apart.
 2. The apparatus of claim1 wherein the instrument markers include a machine readable markingcomprising at least one of: a bar code; a RFID sensor; a UPC, EAN orGTIN; an alpha, numeric or alpha-numeric sequential marking; and/or aneasy coding scheme that is readily identifiable by a human for redundantchecking purposes.
 3. The apparatus of claim 1 wherein the instrumentmarker and controller interact as an orientation agnostic system that iscapable of tracking movement and/or detecting position of the pluralityof medical instruments via the instrument marker regardless of whatorientation or position each medical instrument or instrument marker isin at any given time.
 4. The apparatus of claim 1 wherein the instrumentmarker is hydrophobic to improve machine readability of the instrumentmarker.
 5. The apparatus of claim 1 wherein the instrument marker isformed on the medical instrument via etching, engraving, embossing,carving, molding, stamping, pressing, painting, printing, or vapordeposition.
 6. The apparatus of claim 1 further including machinedetectable zone markers for delineating the physical zones.
 7. Theapparatus of claim 6 wherein the machine detectable zone markers havefirst and second sides, with machine readable information on the firstside and a fastener on the second side for fastening the machinedetectable zone markers to a surface, the fastener including at leastone of: an adhesive; a hook or loop fastener portion; a clasp or clamp;a zipper; and/or a thread.
 8. The apparatus of claim 6 wherein themachine detectable zone markers include a machine readable markingcomprising at least one of: a bar code; a RFID sensor; a UPC, EAN orGTIN; and/or an alpha, numeric or alpha-numeric sequential marking. 9.The apparatus of claim 6 wherein the zone markers are formed on medicaldrapes or coverings for at least one of a surgical instrument table,patient, operating table or patient support, surgical equipment, and/orwaste container.
 10. The apparatus of claim 1 wherein the camera bothcontinually tracks movement and detects position of the plurality ofmedical instruments and the display displays specific data pertaining toboth the spatial movement and position of the plurality of medicalinstruments.
 11. The apparatus of claim 10 wherein the specific datapertaining to spatial movement includes tracking at least two of a xcoordinate, a y coordinate and/or a z coordinate of the at least one ofthe plurality of medical instruments and the specific data pertaining tolocation includes an identification of what zone the at least one of theplurality of medical instruments is currently located.
 12. The apparatusof claim 1 wherein the controller uses the camera to track medicalinstrument data including one or more of location, velocity or speed oftravel, vector or direction of travel, and/or telemetry.
 13. Theapparatus of claim 6 wherein the physical zones further include a thirddiscard zone which is delineated by the machine detectable zone markers.14. The apparatus of claim 1 wherein the apparatus includes a userinterface for locating a missing medical instrument from the pluralityof medical instruments.
 15. The apparatus of claim 14 wherein the userinterface is at least one graphical user interface located on thedisplay that, when actuated, the controller displays on the display animage or video of the missing medical instrument prior to the missingmedical instrument going missing to assist with locating the missingmedical instrument.
 16. The apparatus of claim 19 wherein the controlleris configured such that a single actuation of the at least one graphicaluser interface allows video of the missing medical instrument to bepulled-up on the display and queued up to a period of time at or nearwhen the missing medical instrument went missing which a user can reviewand replay as desired.
 17. An apparatus for tracking medical instrumentsthroughout a procedure comprising: a camera for tracking movement anddetecting position of a plurality of medical instruments during amedical procedure as at least one of the plurality of medicalinstruments is moved between multiple zones at least including a firstprep zone and a second procedure zone; a controller connected to andcollecting images from the camera; and a display in electricalcommunication with the controller or the camera for displaying medicalinstrument data pertaining to the movement and/or position of theplurality of medical instruments including an image or video of anymissing medical instrument prior to the missing medical instrument goingmissing to assist with locating the missing medical instrument; andwherein the controller uses the camera to track medical instrument dataincluding one or more of location, velocity or speed of travel, vectoror direction of travel, and/or telemetry of each medical instrument. 18.The apparatus of claim 17 further comprising at least one graphical userinterface located on the display that, when actuated, the controllerdisplays on the display the image or video of the missing medicalinstrument prior to the missing medical instrument going missing toassist with locating the missing medical instrument.
 19. The apparatusof claim 18 wherein the controller is configured such that a singleactuation of the at least one graphical user interface allows video ofthe missing medical instrument to be pulled-up on the display and queuedup to a period of time at or near when the missing medical instrumentwent missing which a user can review and replay as desired.
 20. Theapparatus of claim 17 further including an alarm for indicating at leastone of the following alarm conditions: a medical instrument missing fromall of the physical zones; a medical instrument detected in an undesiredzone; a medical instrument detected in a zone for too long of a timeperiod; a medical instrument moved out of a predetermined orderestablished for the medical procedure involved; and/or a medicalinstrument moved out of a predetermined order established for themedical personnel involved.
 21. The apparatus of claim 20 wherein thealarm is at least one of: an audible alarm; a visual alarm; and/or atactile or haptic alarm.
 22. The apparatus of claim 20 wherein the alarmis both an audible alarm and a visual alarm, the audible alarm being aspeaker emitting an announcement announcing that at least one of theplurality of medical instruments has gone missing and the visual alarmis a flashing indicator on the display identifying the at least one ofthe plurality of medical instruments that has gone missing.
 23. Theapparatus of claim 20 wherein the controller and/or display includes auser interface for suspending or delaying the alarm.
 24. The apparatusof claim 20 wherein the apparatus stores video into a memory device thata user can access for replay to either review a procedure or track anyof the plurality of medical instruments used during the procedure.